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Defining Human Subjects Research

Human subjects research is any research or clinical investigation that involves human subjects. The federal regulations define a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., survey) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 

Not all research that involves people is "human subjects research" but instead the individual is a "human source." The term “human source” defines situations where a researcher is interacting with another individual to gain knowledge about something but isn’t collecting personal information about that person. For example, the researcher wants to know the current policies for dealing with bulling at a school, so he calls a school administrator to ask that person about the school’s bullying policy and how it was developed, but does not ask about the administrator’s personal experience and how she felt about the policy. The school administrator is a human source but does not become a human subject until she provides personal information about her experience with the policy, bullying, etc. For more examples, please see Examples of Activities that Do and Do Not Require IRB Review.

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